Bisolvon mucolytic 1.6 mg/ml syrup

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Bisolvon Mucolytic 1.6 mg/ml syrup

Bromhexine hydrochloride

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

Follow exactly the instructions for administration of the medicine contained in this leaflet or those indicated by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
• You should consult a doctor if you worsen or do not improve after 5 days.

Contents of the leaflet

1. What Bisolvon Mucolytic is and what it is used for
2. What you need to know before taking Bisolvon Mucolytic
3. How to take Bisolvon Mucolytic
4. Possible adverse effects
5. How to store Bisolvon Mucolytic
6. Contents of the pack and other information

1. What Bisolvon Mucolytic is and what it is used for

Bromhexine, the active substance of this medicine, belongs to the group known as mucolytics, which work by reducing the viscosity of mucus secretions, thereby liquefying them and facilitating their elimination.

This medicine is indicated for reducing the viscosity of mucus and phlegm, thus facilitating their expulsion, in colds and flu.

You should consult a doctor if symptoms worsen or do not improve after 5 days of treatment.

2. What you need to know before starting to take Bisolvon Mucolytic

During the first days of treatment, as secretions become more fluid, you may notice an increase in mucus and phlegm, which will gradually decrease over the course of treatment.

Do not take Bisolvon Mucolytic:

• if you are allergic to bromhexine or to any of the other ingredients of this medicine (listed in section 6).
• Do not use in children under 2 years of age.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Bisolvon Mucolytic.

Cases of serious skin reactions have been reported in association with administration of hydrochloride bromhexine. If you develop a skin rash (including lesions of mucous membranes such as in the mouth, throat, nose, eyes, and genitals), stop using Bisolvon Mucolytic and consult your doctor immediately.

You should consult your doctor before taking this medicine if you have:

• Severe liver disease
• Severe kidney disease
• If you have asthma or a history of asthma, suffer from any severe respiratory disease, or have difficulty coughing
• If you suffer from conditions that predispose you to gastrointestinal bleeding, such as stomach or duodenal ulcer.

Children and adolescents

Do not give this medicine to children under 12 years of age without consulting a doctor. Children under 2 years of age must not take this medicine; it is contraindicated in this age group.

Other medicines and Bisolvon Mucolytic

Taking Bisolvon Mucolytic with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. Do not administer together with antitussive medicines (for cough) or with those that reduce bronchial secretions, as this could lead to accumulation of liquefied mucus. No negative interactions have been reported with antibiotics.

Taking Bisolvon Mucolytic with food and drinks

Taking this medicine with food and drinks does not affect the effectiveness of treatment.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you might be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

No studies have been conducted on the effects of Bisolvon Mucolytic on human fertility.

This medicine should not be used during pregnancy or breastfeeding.

Driving and using machines

During treatment with this medicine, dizziness may occasionally occur; therefore, if you feel dizzy, do not drive or operate machinery.

Bisolvon Mucolytic contains maltitol liquid

This medicine contains liquid maltitol. If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine.

It may produce a mild laxative effect because it contains 2.5 g of liquid maltitol per 5 ml.

Calorific value: 2.3 kcal/g of maltitol/isomaltose.

Bisolvon Mucolytic contains benzoic acid

This medicine contains 1.27 mg of benzoic acid per ml. Benzoic acid may increase the risk of jaundice (yellowing of the skin and eyes) in newborns (up to 4 weeks of age).

3. How to take Bisolvon Expectorant

Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

The recommended dose is:

Adults and children over 12 years: take 10 ml (16 mg) per dose, 3 times a day. Do not exceed a daily dose of 30 ml (48 mg).

Use in children and adolescents: children between 2 and 12 years of age must not take this medicine without first consulting a doctor.

How to take:

This medicine is taken orally.

Measure the dose using the dosing cup provided.

It is recommended to drink a glass of water or any other liquid after each dose, and to drink plenty of fluids throughout the day.

• If symptoms persist after 5 days of treatment, or if fever, skin rashes, persistent headache, or sore throat occur, consult your doctor.

If you take more Bisolvon Expectorant than you should:

If you have taken more Bisolvon Expectorant than recommended, adverse effects—especially those affecting the stomach and intestines—may become more severe. Contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number: 915.620.420, indicating the medicine and the amount ingested.

If you forget to take Bisolvon Expectorant

Do not take a double dose to make up for a missed dose.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Bisolvon Expectorant may cause adverse effects, although not everyone experiences them.

• Uncommon adverse effects (may affect up to 1 in 100 people):
• Vomiting, diarrhoea, nausea, upper abdominal pain.
• Rare adverse effects (may affect 1 in 1,000 people):
• Hypersensitivity reactions
• Bronchospasm (airway constriction in the lungs)
• Exanthema, urticaria.
• Frequency not known (cannot be estimated from available data):
• Anaphylactic reactions, such as anaphylactic shock, angioedema (rapidly progressive swelling of the skin, subcutaneous tissues, mucous membranes, or submucosal tissues), and pruritus.
• Dizziness and headache
• Gastric burning sensation
• Increased transaminase levels (liver enzymes)
• Serious skin reactions (such as erythema multiforme, Stevens-Johnson syndrome/toxic epidermal necrolysis, and acute generalized exanthematous pustulosis).

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: http://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Bisolvon Mucolytic

No special storage conditions are required.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Do not use this medicine more than 12 months after first opening the container.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at a SIGRE collection point in your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Package contents and other information

Composition of Bisolvon Mucolytic Syrup

• Each ml of syrup contains 1.6 milligrams of Bromhexine hydrochloride as the active substance.
• The other components (excipients) are: liquid maltitol (E965), benzoic acid (E-210), sucralose, cherry flavor, chocolate flavor, levomenthol, and purified water.

Appearance of the product and contents of the pack

Bisolvon Mucolytic is a nearly colourless syrup with a fruity odour.

It is presented in an amber glass bottle containing 200 ml of syrup, and includes a dosing cup.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Opella Healthcare Spain, S.L.

C/ Rosselló i Porcel, 21

08016 Barcelona,

Spain

Manufacturer:

Delpharm Reims, S.A.S.

10 Rue Colonel Charbonneaux

51100 Reims

France

Date of the most recent revision of this leaflet: November 2025

QR Code

You can access detailed information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the leaflet. You can also access this information at the following web address: https://cima.aemps.es/cima/dochtml/p/66548/P_66548.html

Additional information for the patient

Some colds and flu may be accompanied by mucus buildup in the respiratory tract. Sometimes, this mucus becomes thick and adheres to the walls of these passages.

This explains why coughing occurs during these conditions, as a defense mechanism of the body to expel phlegm and clear the respiratory tract.

Bromhexine helps liquefy the adhered mucus, loosening it from the airway walls. At the end of the cold or flu, mucus production decreases, and consequently, the need for coughing to eliminate it also diminishes.

Detailed information about this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS): http://www.aemps.gob.es/.